This pilot clinical trial studies the side effects of sorafenib tosylate before and after donor bone marrow transplantation in treating patients with acute myeloid leukemia. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Proportion of patients removed from the study in each cohort due to toxicity [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Will be reported with exact binomial proportions and 95% confidence intervals. All toxicities by type and grade will be reported. The proportion of patients with graft failure in each cohort will also be reported with exact binomial proportions and 95% confidence intervals.

Secondary Outcome Measures:

Cumulative incidence of NRM and relapse [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated by competing risks analysis using Grey's method.

DFS [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Standard life table methods with Kaplan-Meier (KM) plots will be used to analyze DFS. Reported with 90% confidence intervals overall and by cohort.

OS [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Standard life table methods with KM plots will be used to analyze OS. Reported with 90% confidence intervals overall and by cohort.

Change in MRD by flow cytometry [ Time Frame: Baseline to day 365 ] [ Designated as safety issue: No ]

Box plots will be used.

Change in FLT3 suppression by PIA and western blotting [ Time Frame: Baseline to day 365 ] [ Designated as safety issue: No ]

Box plots will be used.

Pharmacodynamic parameters of sorafenib tosylate [ Time Frame: Up to 2 years post transplant ] [ Designated as safety issue: No ]

Samples will be collected to assess sorafenib and the N-oxide metabolite (total and unbound) exposure to correlate with pharmacodynamic endpoints using non-parametric statistics.

Patients receive sorafenib tosylate PO BID beginning at least 30 days after completion of induction therapy and/or transplant and no more than 120 days after transplant continuing for up to 2 years after transplant in the absence of disease progression or unacceptable toxicity.

Drug: Sorafenib Tosylate

Given PO

Other Names:

BAY 54-9085

Nexavar

SFN

Procedure: Bone Marrow Transplantation

Undergo BMT

Other Names:

BMT

Bone Marrow Grafting

Bone Marrow Transplant

Bone Marrow Transplantation

Marrow Transplantation

Other: Pharmacological Study

Correlative studies

Other Name: pharmacological studies

Other: Laboratory Biomarker Analysis

Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the toxicity and safety of incorporation of sorafenib tosylate (sorafenib) into the pre- or post-transplant maintenance setting for three types of transplants.

SECONDARY OBJECTIVES:

I. Improvement of 2 year disease free survival after bone marrow transplant by 25% based on a baseline relapse free survival at two years of 30%.

II. Secondary graft failure is defined as the decline in neutrophil count to < 500/cu mm after achieving engraftment which is unrelated to infection or drug effect (sorafenib?) and is unresponsive to stimulation by growth factors.

III. Non-relapse mortality (NRM) is defined, as death in the absence of competing risks, relapse or progression of disease.

IV. Survival without relapse or death (disease-free survival [DFS]) or without death (overall survival [OS]) will be determined and presented as Kaplan-Meier estimates at 1 and 2 years post-transplant.

V. Patients will be evaluated for chronic graft versus host disease (GVHD) both as described in the National Institute of Health (NIH) consensus project guidelines and by conventional criteria.

Patients receive sorafenib tosylate orally (PO) twice daily (BID) beginning at least 30 days after completion of induction therapy and/or transplant but no more than 120 days after transplant continuing for up to 2 years after transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 24 months.

Eligibility

Ages Eligible for Study:

19 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Acute myeloid leukemia with a FLT3-Internal tandem duplication (ITD) who are in a complete remission or partial remission (less than 10% blasts in marrow) as documented by bone marrow biopsy and who plan to undergo a bone marrow transplantation

Patients who have had count recovery (absolute neutrophil count [ANC] > 500,000/mm^3 non transfused platelet count over 30,000/mm^3 and are at least 30 days after induction and/or transplantation but no more than 120 days post transplant

Patients may have received any prior therapy deemed necessary for induction of remission except for patients whom have progressed while on sorafenib; patients who have responded to sorafenib previously are eligible for enrollment on the protocol

Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; contraception should continue for at least 30 days after the last dose of sorafenib

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 2 weeks except for intrathecal chemotherapy (i.e., methotrexate, cytarabine, or thiotepa)

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01578109